Measurement, Testing and Quality Control

Dr. Amal Al-RashdanManager,Central Analytical Laboratory

Kuwait Institute for ScientificResearch

OUTLINE

1. Introduction to Quality Concept2. What is Quality Control? 3. Effective Quality Control Program4. What is Quality Assurance? 5. Why is QA Important ? 6. QA in Laboratory – Basic Elements• Input Control• Resource Control• Method Control

1 .Quality Concept

• Essential commodities for life -water -food-air-medications

• Are tested by laboratories.• Results must provide accurate

information.• This is a complex issue.• Therefore, organizations and agencies

setup own standards for accepting laboratory data.

• Acceptance may be called accreditation or certification.

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General Terms –Quality –What does that Mean?

• “Quality means that the customer comes back, and not the product”

• Quality and Liability are tightly connected

Quality

A very important remark : “ No data is better than poor data”

2 .What is Quality Control?

Quality Control (QC) refers to the

Specific activities such as Control check samples, control Charts, audits and corrective actions..

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Importance Of Quality Control

Successful laboratories inevitably place great emphasis on managing quality control - carefully planned steps taken to ensure that their services/results offered to their customers are consistent and reliable and truly meet their customers' needs.

3 .Effective Quality Control Program

• Facilitates continuous improvement • Increases customer satisfaction • Promotes the use of quality

principles, concepts, and technologies

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4 .What Is Quality Assurance?

Quality Assurance means the overall plan and system in which quality control takes place.

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4 .What Is Quality Assurance?

• Quality assurance system requirements of laboratories conducting measurements, analyses and calibration activities are defined by the standards ISO 9001:2008 and ISO/IEC 17025:2005.

• QA is applicable to all organizations regardless of type, size and products/services provided.

Quality Assurance

Laboratory Quality Assurance (QA) encompasses a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of samples tested.

Quality Assurance

A good QA system does these four things: • Establishes standard operating procedures (SOPs) for each step of

the laboratory testing process, ranging from sample handling to instrument performance validation;

• Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs;

• Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and

• Sustains high-quality employee performance.

Quality Assurance and Quality Control

• Quality Assurance and Quality Control are the back bone of any organization.

• They are essential for obtaining consistent good quality products (results) and providing good quality services to achieve and maintain customer satisfaction.

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Quality Control & Quality Assurance

• Quality Control/Quality Assurance promotes quality culture in all laboratories through

development and implementation of harmonized working procedures and monitor the effectiveness through internal audits.

• All testing and calibration methods are documented and validated which improves the accuracy of results and minimize the chances of errors.

5 .WHY IS QA IMPORTANT?

• Quality assurance is the main pillar of any types of laboratories (i.e

analytical, clinical and etc.). Quality is the most important aspect, which affects the level of success of the laboratories. One should never ever compromise with the quality aspect. The reputation of laboratories will enhance, only if you provide quality.

• Defined qualification for every personnel requirement results in selection of right personnel for right job.

5 .WHY IS QA IMPORTANT?

• Defined job description eliminates confusions and enhances the work output.

• Training need assessment helps in continues growth of individuals and overall organization.

5 .WHY IS QA IMPORTANT?

• All testing and calibration methods are documented and validated which improves the accuracy of results and minimize the chances of errors.

• All activities are documented and performed according to written procedures which results in reduction of chances of mistakes and elimination of errors.

5 .WHY IS QA IMPORTANT?

• The QA unit will serve both guiding and monitoring function for continuous improvement laboratories. This will lead to generation of consistent good quality results with ultimate achievement of customer satisfaction.

5 .WHY IS QA IMPORTANT?

• QA defined with responsibilities and authorities which eliminate confusions and results in better efficiencies of individuals and overall organization.

5 .WHY IS QA IMPORTANT?

• QA leads in development of team work sprit and combined efforts.

5 .WHY IS QA IMPORTANT?

• It provides a mechanism for handling of customer complaints which leads to identification of corrective and preventive actions and finally eliminates chances of re-occurrence.

• Customer satisfaction is achieved through better service and reliable results.

Human Aspects of Quality Assurance

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Quality Issues For Consideration By Staff

People provide strength to a QC/QA program through

1. Highly trained and competent2. Possess strong work ethic.3. Possess a can-do attitude.4. Hard work5. Real team players.6. Dedication to QC/QA program.

Types Of Quality Control

• Internal Quality Control

• External Quality Control

General Terms – Internal Quality Control

Set of procedures undertaken by laboratory staff for the continuous monitoring of operations and the results of measurements in order to decide whether results are reliable enough to be released.

(IUPAC Orange book)

Internal Quality Control

• Internal QC includes:– blanks– chemical calibration– spiked samples– blind samples– replicate analysis– QC samples– control charts (recommended)

External Quality Control

– e.g. proficiency testing (external quality assessment)

– participation in proficiency testing schemes

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Quality Management

Quality Assurance

Quality Control

InspectionInspection

Quality Control

Quality Assurance

Quality Management

Evolution of Quality

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Equipments

Quality Assurance in Laboratory

Basic ElementsInput Control Resource Control Method Control

Building & Working

Environment

PersonnelSuppliers

Customers

Sampling

Calibration

Testing

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Quality Assurance in Laboratory

Input Control

1. Suppliers • Procedure for selection and approval of suppliers.• Procedure for reception and storage of purchased items.• Clear specifications of required items and services.• Inspection and verification of purchased items against

specifications.• Proper storage and record keeping of purchased items.• Suppliers history/record.

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Quality Assurance in Laboratory

Input Control2. Customers• Procedure for interaction and service to the customers.• Procedure for handling customers complaints and

corrective/preventive actions and record.• Clear and unambiguous requirements from customers.• Good communication and guidance (if required).• Customers feed back.• Customers history/record.

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Quality Assurance in Laboratory

Resource Control1. Personnel • Defined Job Specifications (qualification, experience).• Defined Job Descriptions (responsibilities & authorities).• Appropriate competence of staff. Trained to perform required

job.• Training need identification and implementation on regular

basis. Training record.• Staff motivation, Good communication, Team work.

Right Person For The Right Job

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Quality Assurance in LaboratoryResource Control

2. Building & Work Environment • Building design should meet health & safety requirements.• Adequate energy sources, lighting and environmental

conditions which facilitate correct analysis work.• Control, monitor and record environmental conditions as per

specific requirements.• Effective separation from neighboring areas and prevention

from cross contamination.• Controlled access and use.• Regular and Good housekeeping.

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Quality Assurance in Laboratory

Resource Control3. Equipments • Coding and tagging of equipments for traceability.• Appropriate capability of equipment and its software.• Handling by competent, trained staff.• SOP for operation and record.• SOP for calibration and record.• SOP for routine cleaning/maintenance and record.• SOP for safeguard the equipment.• Equipment History. Right Equipment For The Right Test

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Quality Assurance in Laboratory

Method Control

1. Sampling • Sampling plan and procedures.• Uniform sampling by trained staff.• Use of appropriate sampling equipment and sample

container. • Appropriate labeling.• Appropriate environmental conditions during transportation,

handling and storage. • Handover to authorized person for testing.• Sampling record.

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Quality Assurance in Laboratory

Method Control

2. Calibration • SOPs for calibration of equipments including calibration

schedule.• Calibration by trained staff.• Use of appropriate standards and certified reference

materials.• Performance check by analyzing check standards and certified

reference materials.• Calibration record.

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Quality Assurance in Laboratory

Method Control3. Testing • SOPs for testing.• Appropriate method should be used to perform test.• Preferably standard methods published by international

organizations e.g. ASTM, ISO, EPA, US FDA etc.• Non standard methods and Laboratory-developed methods

should be validated.• Performance check by analyzing check standards, spiked

samples and certified reference materials.• Testing record.

THANKS FOR YOUR ATTENTION